(32 days)
Use of HardyDiskTM AST Delafloxacin 5ug (DLX5) , for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin.
The concentration of Delafloxacin 5pg (DLXS), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains) Staphylococcus haemolyticus Streptococcus pvogenes Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa
The concentration of Delafloxacin 5ug (DLXS), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use: Streptococcus dvsgalactiae Enterobacter aerogenes Haemophilus parainfluenzae Klebsiella oxytoca Proteus mirabilis
HardyDiskTM AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Not Found
The provided text describes the regulatory clearance of a medical device (HardyDisk AST Delafloxacin 5 ug (DLX5)) and outlines its indications for use. However, it does not contain information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood in a performance evaluation context.
The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It confirms the device can be marketed but does not delve into the detailed performance metrics, study designs, or ground truth establishment that would be present in a clinical or analytical performance study report.
Therefore, many of the requested items (e.g., table of acceptance criteria, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) cannot be extracted from this document.
Here's what can be stated based on the provided text:
1. A table of acceptance criteria and the reported device performance:
* Not provided. This document is a clearance letter, not a performance study report. It does not contain a specific table outlining acceptance criteria or results of a performance study demonstrating those criteria were met for metrics like sensitivity, specificity, accuracy, etc.
2. Sample size used for the test set and the data provenance:
* Not provided. The document does not describe the test set used for performance evaluation, nor does it mention sample sizes or data provenance (country of origin, retrospective/prospective). To attain 510(k) clearance for antimicrobial susceptibility tests, studies are generally performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines, which specify testing a certain number of isolates (typically challenge and clinical isolates) to demonstrate performance against reference methods. However, the details of such a study are not in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided. This information would be specific to how the ground truth for an analytical or clinical performance study was established, which is not detailed here.
4. Adjudication method for the test set:
* Not provided. This is relevant to studies involving human interpretation or expert review, which is not discussed in this regulatory clearance letter.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable/Not provided. This device is an antimicrobial susceptibility test disk. It's not an AI-powered diagnostic device that involves human readers interpreting images or data with or without AI assistance. Therefore, an MRMC study and effects on human reader performance are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided. This is not an algorithmic device. The "performance" of such a disk is evaluated by its ability to accurately determine bacterial susceptibility (zone diameter measurements corresponding to MICs), usually read visually by a trained microbiologist or with an automated reader. The document does not describe a standalone "algorithm only" performance.
7. The type of ground truth used:
* Inferred based on device type, but not explicitly stated in the document. For antimicrobial susceptibility tests, the "ground truth" is typically established by a reference method, such as broth microdilution or agar dilution minimum inhibitory concentration (MIC) testing, often performed in accordance with CLSI standards. The HardyDisk AST Delafloxacin 5ug (DLX5) is used for "in vitro agar diffusion susceptibility testing," implying comparison to a recognized reference method to determine true susceptibility/resistance.
8. The sample size for the training set:
* Not applicable/Not provided. This device is a physical disk for a laboratory test, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
* Not applicable/Not provided. As above, no training set is relevant for this device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing, with a double-serpentine design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1. 2017
HARDY DIAGNOSTICS RIANNA MALHERBE LEAD PERFORMANCE STUDIES MICROBIOLOGIST 1430 WEST MCCOY LANE SANTA MARIA CA 93455
Re: K171975
Trade/Device Name: HardyDisk AST Delafloxacin 5 ug (DLX5) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: II Product Code: JTN Dated: June 29, 2017 Received: June 30, 2017
Dear Ms. Malherbe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171975
Device Name HardyDiskTM AST Delafloxacin 5ug (DLX5)
Indications for Use (Describe)
Use of HardyDisk™ AST Delafloxacin 5μg (DLX5) , for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin.
The concentration of Delafloxacin 5pg (DLXS), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains) Staphylococcus haemolyticus Streptococcus pvogenes Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa
The concentration of Delafloxacin 5ug (DLXS), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use: Streptococcus dvsgalactiae Enterobacter aerogenes Haemophilus parainfluenzae Klebsiella oxytoca Proteus mirabilis
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | --------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).